Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
ObjectiveTo analyze the current situation of adaptation guidelines. MethodsCBM, CNKI, VIP, WanFang Data, PubMed, EMbase, GIN, SIGN, NICE and AHRQ databases were electronically searched to collect studies related to adaptation guidelines from inception to August 31th, 2020. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Descriptive analysis was then conducted on the general situation of the adaptation guidelines. ResultsA total of 83 studies were included, involving 63 full-text studies, 16 methodological studies and 4 secondary studies. The quantity of published articles of the adapted guidelines had an overall upward trend, and 48.39% of the adapted guidelines were published in UK-hosted journals. 51.81% of the adapted guidelines reported receiving funding or project funding during the development process, and 67.46% reported information of conflict of interests. Among the 33 adaptation guidelines published in the past five years, 33.34% reported their methodology used ADAPTE, 6.1% reported their methodology used GRADE-Adolopment, and 60.56% did not report the adaptation method. ConclusionsAt present, the international research on the adapted guideline is extensive, however, it is still in its infancy in China. The adaptation guideline is also required to be based on a theoretical framework, standardize the development of methodology, and ensure the quality of the adaptation guideline.
ObjectiveTo select the key questions of the reporting quality of acupuncture therapy network meta-analysis. MethodsA question pool about reporting quality of acupuncture therapy network meta-analysis was conducted by preliminary literature research and qualitative systematic review. A correspondence questionnaire was designed and the selection of key questions was carried out through two rounds of expert consultation using the Delphi method. ResultsA total of 21 key questions were selected for the network meta-analysis report standard of acupuncture, including whether to report details of acupuncture interventions (e.g., needle type, acupoints used, number of needles inserted, depth of needle insertion, retention time, needling techniques, and treatment duration), diagnostic criteria for diseases or traditional Chinese medicine syndromes, and qualifications of acupuncture practitioners. Of these, the only three key questions answered by the preferred reporting items for systematic reviews and network meta-analysis (PRISMA-NMA) were summary, protocol and registration, and source of funding, while the remaining 19 were specific to acupuncture-related report standards. ConclusionThe conducted key question on reporting guideline of acupuncture network meta-analysis can improve the standardization and rigor of relevant research and better utilize its academic and clinical value.
ObjectivesTo evaluate the reporting status of conflict of interest and economic evidence in Chinese clinical practice guidelines published in 2017 and to provide implications for the guideline development in China.MethodsCNKI, WanFang Data and Google Scholar were electronically searched to collect clinical practice guidelines published in 2017 from January 1st to December 31st, 2017. Two authors independently screened literature, extracted information of interest, such as conflict of interest disclosure and economic evidences, then, the analysis was performed by using the Microsoft Excel 20013 software.ResultsA total of 53 guidelines were included; in which, 14 (26.42%) disclosed conflict of interest, 10 (18.87%) stated sources of funding, and 6 (11.32%) mentioned economics evidence.ConclusionIn China, inadequate attention is addressed to the conflict of interest disclosure and economics evidence during the development of clinical practice guidelines. We propose the inclusion of conflict of interest and economics evidence disclosure in clinical practice guidelines, which will improve their objectivity, independence, and transparency.
The UK's National Institute for Health and Care Excellence (NICE) published guideline of mental wellbeing at work on March 2, 2022. The guideline covers how to create the right conditions for mental wellbeing in the workplace, with the aim of promoting supportive and inclusive workplace environments and helping people with or at potential risk of mental health problems. This review will interpret the guidelines in detail.
ObjectivesTo assess the methodological quality of clinical practice guidelines of cervical cancer in China published from 2014 to 2018.MethodsCNKI, WanFang Data, CBM, VIP, Medlive.cn, the National Guideline Clearinghouse, PubMed, The Cochrane Library and EMbase were searched for cervical cancer clinical practice guidelines published in China from January 1st, 2014 to December 31st, 2018. Four reviewers searched and selected the literature independently according to the inclusion and exclusion criteria and assessed the methodological quality of the included guidelines by using AGREE Ⅱ.ResultsA total of 9 guidelines were included. The average score for each area was: scope and purpose 75.47%, stakeholders’ involvement 35.09%, the rigor of development 43.70%, clarity of presentation 87.74%, applicability 80.76%, and editorial independence 0%.ConclusionsThe quality of cervical cancer clinical practice guidelines in China requires further improvement.
Objective To evaluate the methodological and reporting quality of clinical guidelines and consensus for adult AIDS. Methods Databases including PubMed, EMbase, Web of Science, CBM, WanFang Data and CNKI were electronically searched and major guideline websites such as GIN, NICE, NGC and Yimaitong were also searched to collect guidelines and consensus for adult AIDS from inception to December 2021. Two researchers independently screened the literature and extracted data according to the inclusion and exclusion criteria. Four reviewers evaluated the methodological and reporting quality of the included guidelines and consensus by using AGREE Ⅱ and RIGHT, respectively. Results A total of 17 adult AIDS guidelines and consensus were included. The average scores of AGREE Ⅱ in various domains were 59.48% for scope and purpose, 37.17% for stakeholder involvement, 30.76% for rigor of development, 74.75% for clarity of presentation, 35.54% for applicability, and 50.49% for editorial independence. The items with the highest reporting rate among the RIGHT evaluation items were 1a, 1b and 1c (100.00%), followed by 3 and 4 (94.12%), 13a and 13b (88.24%), 7b and 11a (76.47%), and 5 (64.71%), and the remaining items were all reported below 60%. Results of subgroup analysis showed that the clarity of presentation, applicability and editorial independence of the guidelines for adult AIDS expressed in AGREE Ⅱ and the average score of RIGHT were higher than those of the consensuses for adult AIDS; the average scores of guidelines and consensuses based on evidence-based medicine in five domains of AGREE Ⅱ (scope and purpose, stakeholder involvement, rigor of development, clarity of presentation and applicability) and RIGHT were higher than those based on expert opinions or reviews. The foreign guidelines and consensus had higher average scores in the six domains of AGREE Ⅱ and the RIGHT score than the domestic guidelines. Conclusion The methodological quality and reporting quality of the published clinical guidelines and consensuses for adult AIDS is low; in particular, there is a certain gap between the national and international guidelines and consensuses. It is suggested that future guideline developers should refer to international standards, such as AGREE Ⅱ and RIGHT, formulate high-quality guidelines and promote their application to better regulate the diagnosis and treatment of adult AIDS.
Objective To design a new type of three-dimensional honeycomb guide for percutaneous cannulated screw placement in femoral neck fracture and evaluate its effectiveness. Methods The clinical data of 40 patients with femoral neck fracture who met the selection criteria between June 2019 and December 2020 were retrospectively analyzed. According to different intraoperative positioning methods, they were divided into control group (20 cases, free hand positioning screws) and study group (20 cases, new guide assisted positioning screws). There was no significant difference in gender, age, side, cause of injury, Garden classification, and time from injury to operation between the two groups (P>0.05). The operation time, fluoroscopy times, guide needle puncture times, and fracture healing time of the two groups were recorded. The hip function was evaluated by Harris score at last follow-up. At immediate after operation, the following imaging indexes were used to evaluate the accuracy of screw implantation distribution: screw spacing, screw coverage area, distance from screw to cervical cortex, parallelism between screws, and screw to cervical axial deviation. Results All operations were successfully completed, and the guide needle did not penetrate the femoral neck cortex. There was no significant difference in operation time and fluoroscopy times between the two groups (P>0.05); the guide needle puncture times in the study group was significantly less than that in the control group (t=8.209, P=0.000). Imaging detection at immediate after operation showed that the screw spacing and screw coverage area in the study group were significantly greater than those in the control group (P<0.05); the distance from screw to cervical cortex, parallelism between screws, and screw to cervical axial deviation were significantly smaller than those in the control group (P<0.05). All patients were followed up 7-25 months, with an average of 19.3 months. There was no significant difference in follow-up time between the two groups (t=?0.349, P=0.729). There were 2 cases of fracture nonunion in the control group and 1 case in the study group, and the other fractures completely healed. One case of osteonecrosis of the femoral head occurred in the control group. During the follow-up, there was no complication such as vascular and nerve injury, venous thrombosis, screw penetration, withdrawal, breakage, and refracture, etc. There was no significant difference in fracture healing time and Harris score at last follow-up between the two groups (P>0.05). ConclusionThe new three-dimensional honeycomb guide has the advantages of simple structure and convenient use. It can reduce the puncture times of the guide needle and effectively improve the accuracy distribution of cannulated screw implantation.
